Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids

NCT01504308 | Terminated Phase 2 DMC FDA Device

• 2 other identifiers: 994045G110008
• Study Type: interventional
• Target: 49
• Locations: 3 countries
• Sites: 9

Brief Summary

The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatment symptomatic uterine leiomyomas (uterine fibroids).

Conditions

Uterine Fibroids

Keywords

uterine fibroids; uterine leiomyomas; magnetic resonance imaging; focused ultrasound

Outcome Measures

Primary Outcomes (2)

• Alternative Interventional Treatment (AIT)

  AIT is scored dichotomously as follows: 0 = Failure. Failure occurs if an AIT for fibroid related symptoms is administered within 12 months of study treatment. 1 = Success. Success occurs if no AIT is administered for fibroid related symptoms within 12 months of study treatment. An AIT is defined as being one of the following: hysterectomy, myomectomy, uterine artery embolization, endometrial ablation and resection, or another MR-HIFU treatment (with the exception of a 're-treatment' as defined in the protocol, e.g. because of temporarily inaccessible fibroids).

  12 months after HIFU treatment

• Menstrual Blood Loss (MBL)

  Menstrual Blood Loss (MBL) scored dichotomously as follows: 0 = Failure. Failure occurs if the change from baseline in MBL measurement is \< 50 % as measured with alkaline hematin test (AHT) method. 1 = Success. Success occurs if the change from baseline in MBL measurement is \>= 50 %, or if the MBL is \< 80 ml as measured with the AHT method.

  at baseline and at 12 months following treatment

Secondary Outcomes (2)

• Return to Activity

  72 hours

• Symptom Severity Score (SSS)

  at baseline and at 12 months following treatment

Study Arms (2)

MR-HIFU treatment

EXPERIMENTAL

Patients receiving MR-HIFU treatment

Device: MR-HIFU treatment

Sham Treatment

SHAM COMPARATOR

Patients receiving sham treatment

Device: Sham treatment

Interventions

MR-HIFU treatment DEVICE

A treatment session with the Philips Sonalleve MR-HIFU device for thermal ablation of uterine fibroids with high-intensity focused ultrasound.

Also known as: Philips Sonalleve MR-HIFU Uterine Fibroid Therapy

MR-HIFU treatment

Sham treatment DEVICE

A pretend treatment session with the Philips Sonalleve MR-HIFU system in which no therapeutic ultrasound doses are delivered.

Also known as: pretend treatment with Philips Sonalleve MR-HIFU

Sham Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women, age between 18 and 50 years
• Ethnicity has a match with the intended profile for the site
• Weight \< 140kg or 310lbs
• Pre- or peri-menopausal as indicated by clinical evaluation or Follicle Stimulating Hormone (FSH) level \< 40 IU/L
• Willing and able to attend all study visits
• Willing and able to complete Menstrual Blood Loss (MBL) assessment with Alkaline Hematin (AH) method
• Willing and able to use reliable contraception methods
• Uterine size \< 24 weeks
• Cervical cell assessment by Pap smear: Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue
• MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated.
• Fibroids selected for treatment meeting the following criteria (further extrapolated in the protocol):
• Total planned ablation volume of all fibroids should not exceed 250 ml and
• No more than 5 fibroids should be planned for ablation and
• Dominant fibroid (diameter) is greater than or equal to 3 cm and
• Completely non-enhancing fibroids should not be treated as the identification of treated volume becomes ambiguous

You may not qualify if:

• Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis)
• Desire for future pregnancy
• Significant systemic disease even if controlled
• Positive pregnancy test
• Hematocrit \< 25%
• Extensive scarring along anterior lower abdominal wall (\>50% of area)
• Surgical clips in the potential path of the HIFU beam
• MRI contraindicated
• MRI contrast agent contraindicated (including renal insufficiency)
• Calcifications around or throughout uterine tissues that may affect treatment
• Communication barrier
• Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU MR protocol) fibroids
• Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible)
• Menses lasting \> 7 days or intermenstrual bleeding (patient can be included if there is endometrial biopsy within 6 months to exclude malignancy)
• Patient is currently on hormonal medication for fibroids or has a hormonal medication history as described below:

Sponsors & Collaborators

• Philips Healthcare: lead

Study Sites (9)

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Oregon Science and Health University

Portland, Oregon, 97239, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (14)

• Voogt MJ, Trillaud H, Kim YS, Mali WP, Barkhausen J, Bartels LW, Deckers R, Frulio N, Rhim H, Lim HK, Eckey T, Nieminen HJ, Mougenot C, Keserci B, Soini J, Vaara T, Kohler MO, Sokka S, van den Bosch MA. Volumetric feedback ablation of uterine fibroids using magnetic resonance-guided high intensity focused ultrasound therapy. Eur Radiol. 2012 Feb;22(2):411-7. doi: 10.1007/s00330-011-2262-8. Epub 2011 Sep 8.

  PMID: 21901565 BACKGROUND

• Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1.

  PMID: 11814511 BACKGROUND

• Stewart EA, Gedroyc WM, Tempany CM, Quade BJ, Inbar Y, Ehrenstein T, Shushan A, Hindley JT, Goldin RD, David M, Sklair M, Rabinovici J. Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol. 2003 Jul;189(1):48-54. doi: 10.1067/mob.2003.345.

  PMID: 12861137 BACKGROUND

• Hindley J, Gedroyc WM, Regan L, Stewart E, Tempany C, Hynyen K, Mcdannold N, Inbar Y, Itzchak Y, Rabinovici J, Kim HS, Geschwind JF, Hesley G, Gostout B, Ehrenstein T, Hengst S, Sklair-Levy M, Shushan A, Jolesz F. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol. 2004 Dec;183(6):1713-9. doi: 10.2214/ajr.183.6.01831713.

  PMID: 15547216 BACKGROUND

• Leon-Villapalos J, Kaniorou-Larai M, Dziewulski P. Full thickness abdominal burn following magnetic resonance guided focused ultrasound therapy. Burns. 2005 Dec;31(8):1054-5. doi: 10.1016/j.burns.2005.04.019. Epub 2005 Jun 20. No abstract available.

  PMID: 15970389 BACKGROUND

• Fennessy FM, Tempany CM. MRI-guided focused ultrasound surgery of uterine leiomyomas. Acad Radiol. 2005 Sep;12(9):1158-66. doi: 10.1016/j.acra.2005.05.018.

  PMID: 16099686 BACKGROUND

• Stewart EA, Rabinovici J, Tempany CM, Inbar Y, Regan L, Gostout B, Hesley G, Kim HS, Hengst S, Gedroyc WM. Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids. Fertil Steril. 2006 Jan;85(1):22-9. doi: 10.1016/j.fertnstert.2005.04.072.

  PMID: 16412721 BACKGROUND

• Fennessy FM, Tempany CM, McDannold NJ, So MJ, Hesley G, Gostout B, Kim HS, Holland GA, Sarti DA, Hynynen K, Jolesz FA, Stewart EA. Uterine leiomyomas: MR imaging-guided focused ultrasound surgery--results of different treatment protocols. Radiology. 2007 Jun;243(3):885-93. doi: 10.1148/radiol.2433060267. Epub 2007 Apr 19.

  PMID: 17446521 BACKGROUND

• Mara M, Fucikova Z, Maskova J, Kuzel D, Haakova L. Uterine fibroid embolization versus myomectomy in women wishing to preserve fertility: preliminary results of a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2006 Jun 1;126(2):226-33. doi: 10.1016/j.ejogrb.2005.10.008. Epub 2005 Nov 15.

  PMID: 16293363 BACKGROUND

• Stewart EA, Gostout B, Rabinovici J, Kim HS, Regan L, Tempany CM. Sustained relief of leiomyoma symptoms by using focused ultrasound surgery. Obstet Gynecol. 2007 Aug;110(2 Pt 1):279-87. doi: 10.1097/01.AOG.0000275283.39475.f6.

  PMID: 17666601 BACKGROUND

• Taran FA, Tempany CM, Regan L, Inbar Y, Revel A, Stewart EA; MRgFUS Group. Magnetic resonance-guided focused ultrasound (MRgFUS) compared with abdominal hysterectomy for treatment of uterine leiomyomas. Ultrasound Obstet Gynecol. 2009 Nov;34(5):572-8. doi: 10.1002/uog.7435.

  PMID: 19852046 BACKGROUND

• Funaki K, Fukunishi H, Sawada K. Clinical outcomes of magnetic resonance-guided focused ultrasound surgery for uterine myomas: 24-month follow-up. Ultrasound Obstet Gynecol. 2009 Nov;34(5):584-9. doi: 10.1002/uog.7455.

  PMID: 19852041 BACKGROUND

• Okada A, Morita Y, Fukunishi H, Takeichi K, Murakami T. Non-invasive magnetic resonance-guided focused ultrasound treatment of uterine fibroids in a large Japanese population: impact of the learning curve on patient outcome. Ultrasound Obstet Gynecol. 2009 Nov;34(5):579-83. doi: 10.1002/uog.7454.

  PMID: 19852042 BACKGROUND

• Kim YS, Lim HK, Kim JH, Rhim H, Park BK, Keserci B, Kohler MO, Bae DS, Kim BG, Lee JW, Kim TJ, Sokka S, Lee JH. Dynamic contrast-enhanced magnetic resonance imaging predicts immediate therapeutic response of magnetic resonance-guided high-intensity focused ultrasound ablation of symptomatic uterine fibroids. Invest Radiol. 2011 Oct;46(10):639-47. doi: 10.1097/RLI.0b013e318220785c.

  PMID: 21654495 BACKGROUND

MeSH Terms

Conditions

Leiomyoma; Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• John H Fischer II, MD

  St. Luke's Episcopal Hospital, Houston, Texas, United States

  PRINCIPAL INVESTIGATOR

• Robert K Zurawin, MD

  St. Luke's Episcopal Hospital, Houston, Texas, United States

  PRINCIPAL INVESTIGATOR

• Elizabeth David, MD

  Sunnybrook Health Sciences Center, Toronto, Ontario, Canada

  PRINCIPAL INVESTIGATOR

• Hyo Keun Lim, MD

  Samsung Medical Center, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

• Aytekin Oto, MD

  University of Chicago, Chicago, Illinois, United States

  PRINCIPAL INVESTIGATOR

• Amanda Yunker, D.O.

  Vanderbilt Medical Center

  PRINCIPAL INVESTIGATOR

• Peter Liu, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Rajiv Chopra, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 5, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

CA (1); US (7); KR (1)